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A Multicentre Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects with Alagille Syndrome

Trial Profile

A Multicentre Extension Study to Evaluate the Long-Term Safety and Durability of the Therapeutic Effect of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Subjects with Alagille Syndrome

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs Lopixibat chloride (Primary)
  • Indications Alagille syndrome; Cholestasis; Liver disorders
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms IMAGINE
  • Sponsors Lumena Pharmaceuticals; Mirum Pharmaceuticals; Shire
  • Most Recent Events

    • 15 Mar 2019 Planned End Date changed from 30 May 2019 to 31 Dec 2019.
    • 15 Mar 2019 Planned primary completion date changed from 30 May 2019 to 31 Dec 2019.
    • 15 Feb 2019 Planned number of patients changed from 42 to 19.
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